Grant FAQS

Following are some of the questions we have received regarding the application form and the application process for basic science and clinical research grants.  If you do not find the answer to your question here, please contact the AFSH at [email protected].

Application
Explanation of fields 3f and 3h, and sections 4 and 5 on the application form
What needs to be included in the letter of support, and who should it come from?
For the 4a field (Research Exempt) does a human study apply?
Does the ASSH member have to be the PI? Or can he/she be the Sub-I?
Is the ethics application required if the study is still in the review process?
Can non-USA institutes apply for ASSH Clinical Research Grants?
For the "Official Signing for Applicant Organization," who is this supposed to be? Can it be the PI?
Should the budget/budget narrative include the actual costs of the project or the portion being requested from ASSH?
Can a hospital be the applicant for a grant submitted by a doctor?
What should be the start date of the study?
How is a "New Investigator" defined?
Can a research coordinator/research assistance be the “Administrative Official”?
What happens after the application is submitted? When will notifications be sent?
Can the ASSH Active Member sponsor/mentor be from a different institution?

Grant Funds
Can grant funds be used for salary support for a PI?
Does the grant support only direct costs or can it support staff time for data collection and secretary support?
What is the allowance cut-off for minor vs. major pieces of equipment? Is there a dollar amount?
Can the grant money be used to reimburse patients for a study visit that is not a standard of care visit (research related visit only)?

Misc
Can the PI be changed after a grant has been accepted?





Here is an explanation of fields 3f and 3h, and sections 4 and 5 on the application form:

3f- If the applicant is in the Department of General Surgery, then the Major Subdivision might be Plastic Surgery or Orthopaedic Surgery (if it is not a department).  Alternatively if the PI is a rheumatologist, then the department is internal medicine.

3h. If the PI has ever submitted an NIH proposal or has been a Co-Investigator on any NIH proposal, then they must have this name.  If they have not, they should leave it blank.

4.  If the research proposal involves human beings, then check yes and continue with 4.  If it involves animals, then check no and move onto 5.

4a. There are rare situations where the studies are exempt and still involve humans.   Most often, this box should be checked no.

4b. All universities have this number assigned to them.  The PI should be able to obtain this from the university administration.

 4c.  Does this involve a clinical trial?  If so, then check yes. 

4d. This defines if it is a Phase III study- meaning that the animal studies have already been done (phase I) and the human safety studies (phase II) have also been done.  For phase III clinical trial, the PI is determining efficacy of the intervention.

 5.  If the research plan involves animals, then check yes

5a. If animals are being used, then the PI must submit an IACUC protocol and this is the date that the study was approved.

5b. All universities have this number assigned to them.   The PI should be able to obtain this from the university administration.



What needs to be included in the letter of support, and who should it come from?

The letter of support is intended to verify that the researcher will have time (as in time away from clinical practice) and enough resources in addition to the grant to complete the project in a timely fashion.  The letter should come from a Department or Division head or equivalent. 



For the 4a field (Research Exempt) does a human study apply?

Number 4 applies if the research involves human beings/subjects.  If so, they need to have an IRB approval and the necessary other info.



Does the ASSH member have to be the PI? Or can he/she be the Sub-I?

The ASSH member does not have to be the PI -- just simply one of the investigators on the ASSH grant. The person doing the primary share of the work and is ultimately responsible for the project completion should be the PI.



Is the ethics application required if the study is still in the review process?

Applicants need to provide proof that the ethics application has been submitted and is being reviewed. Applicants are not required to have approval at the time of the grant submission.



Can non-USA institutes apply for ASSH Clinical Research Grants?

Yes, as long as an ASSH Active Member is listed on the grant.



For the "Official Signing for Applicant Organization," who is this supposed to be? Can it be the PI?

No, the PI is not the ‘Official Signing for Applicant Organization’. This is the individual in the PI’s university who has signing authority for the university.  Whenever funds are awarded, they are never given directly to the PI.  Rather, they are given to an institution.  With this signature, the sponsoring institution acknowledges that there will not be any indirect costs provided and that they are also responsible for monitoring the research conduct of the PI.  



Should the budget/budget narrative include the actual costs of the project or the portion being requested from ASSH?

This should only include the costs that the PI is requesting from the ASSH.  Most often, the research will often cover more than this amount.  That is part of the PI’s environment for research.



Can a hospital be the applicant for a grant submitted by a doctor?

It can be anybody that has an Institute Research Board or Institute Animal Welfare Committee.



What should be the start date of the study?

A start date of October 1st or November 1st would be appropriate. Since grant letters are mailed out in August, and there is some paperwork that needs to be done prior to the check being sent, give yourself 2-3 months from when you receive the letter to start your study.

 



How is a "New Investigator" defined?

 

A new investigator has not received an R01 or VA merit grant as a Principal Investigator.



Can a research coordinator/research assistance be the “Administrative Official”?

No, the Administrative Official should have oversight over all research activities and is unlikely to be directly involved in the study.



What happens after the application is submitted? When will notifications be sent?

Applications are due in April and distributed to members of the Research Management Committee (RMC) for review and scoring.  In June, the RMC gathers to review the applications and make funding recommendations.  Recommendations are sent to ASSH Council and the AFSH Board of Trustees for approval.  Grant letters are typically mailed out the beginning of August.


Can the ASSH Active Member sponsor/mentor be from a different institution?

The sponsor needs to play a meaningful role on the project and you are strongly encouraged to ask someone from your own organization to act as your sponsor.  However, there is no official policy barring you from asking someone from another institution to be your sponsor.  The overall research environment and contribution of the mentor will be a factor when scoring and reviewing the grant.



Can grant funds be used for salary support for a PI?

Grant funds cannot be used to pay for PI salaries. Funds can be used to support salaries for research assistants.



Does the grant support only direct costs or can it support staff time for data collection and secretary support?

Some funds may be used for lab personnel or research coordinator if explained appropriately in the proposal.  The AFSH does not allow for any Indirect Costs for this proposal.  By having the university officials sign off on the proposal, they are acknowledging and accepting the condition of the grant submission.  



What is the allowance cut-off for minor vs. major pieces of equipment? Is there a dollar amount?

This limit is placed so that the funds are not used by a large lab to purchase another piece of equipment for work that was already to be performed. Roughly, $5,000 is the cut-off for significant purchases requiring approval as capital expenditures.  



Can the grant money be used to reimburse patients for a study visit that is not a standard of care visit (research related visit only)?

As far as patient reimbursement, it would be better if they were referred to as "subjects" - it's less confusing. As long as this is clearly not covering clinical costs for treatment, it is appropriate.



Can the PI be changed after a grant has been accepted?

Since the approval of the project has, to some degree, been based on the participation or qualifications of the PI and other key personnel, the AFSH must be notified whenever there is to be a significant change in the level of participation in the awarded project.  The AFSH has the option to either approve or disapprove of any proposed alternate plans related to the research.  If the arrangements proposed by the grantee, including the qualifications of any proposed replacement, are not acceptable to the AFSH, the grant may be suspended or terminated. If the grantee wishes to terminate the project because it cannot make suitable alternate arrangements, it must notify the AFSH, in writing, of its wish to terminate, and the AFSH will forward closeout instructions.

Significant change in the level of participation may be defined as:

  • The PI not giving active direction of the project for a continuous period of time greater than three months, e.g. sabbatical leave, or
  • A 25% reduction in time devoted to the project.

The AFSH must be notified in a letter signed by the PI detailing the reason for the change in key personnel and provide the replacement PI's biosketch and other supporting documents, as requested.

See the NIH process.